Fluorouracil, Cisplatin, and Radiation Therapy or Gemcitabine and Oxaliplatin in Treating Patients With Nonmetastatic Biliary Tract Cancer That Cannot Be Removed By Surgery

Summary

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, cisplatin, oxaliplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving fluorouracil and cisplatin together with radiation therapy is more effective than giving gemcitabine together with oxaliplatin in treating nonmetastatic biliary tract cancer. PURPOSE: This randomized phase II/III trial is studying fluorouracil, cisplatin, and radiation therapy to see how well they work compared to gemcitabine and oxaliplatin in treating patients with nonmetastatic biliary tract cancer that cannot be removed by surgery.

Timeline

Start

2005-10

Primary completion

2012-12

Completion

2012-12

Publications

• Results Phelip JM, Vendrely V, Rostain F, Subtil F, Jouve JL, Gasmi M, Michel P, Le Malicot K, Smith D, Seitz JF, Fauchart JP, Martin P, Bennouna J, Morin T, Bonnet I, Maingon P, Lepage C, Chauffert B. Gemcitabine plus cisplatin versus chemoradiotherapy in locally advanced biliary tract cancer: Federation Francophone de Cancerologie Digestive 9902 phase II randomised study. Eur J Cancer. 2014 Nov;50(17):2975-82. doi: 10.1016/j.ejca.2014.08.013. Epub 2014 Sep 17.

Drugs

Indications